COlombia DAISe FEasibility Exercise (COFEE)

A Feasibility Study for the DAISe Thrombectomy Device in Colombia

This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.

Study Overview

• Status: Terminated
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Device: DAISe

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Itagüí, Antioquia, Colombia
      • Angiosur - Unidad Vascular Integral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older.
• Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
• Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
• Disabling stroke defined as a baseline NIHSS > 6.
• Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
• Signed informed consent from patient or legal representative.

Exclusion Criteria:

• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
• Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
• Rapidly improving neurological deficits based on the investigator's clinical judgement.
• Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
• Severe contrast allergy or absolute contraindication to iodinated contrast.
• Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
• Evidence of dissection in the carotid or target artery for treatment.
• Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
• Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
• Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP>110 mmHg).
• Use of warfarin anticoagulation with International Normalized Ratio (INR) >3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
• Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
• Cerebral vasculitis or evidence of active systemic infection.
• Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
• Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
• A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAISe; DAISe Thrombectomy Device	Device: DAISe; Use of the DAISe Thrombectomy Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful Revascularization	mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device	Procedure
Rate of Symptomatic Intracranial Hemorrhage		24 hours post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Procedure related Complications		Through 90 day post-procedure
Occurrence of all intracranial hemorrhage		24 hours post-procedure
All-cause mortality		Through Acute Hospital Discharge
Embolization to a New Vascular Territory		Procedure
Successful Revascularization after first attempt with DAISe	mTICI (modified TICI) 2b-3 after first pass with device	Procedure
Successful Revascularization after first attempt with DAISe	mTICI (modified TICI) 2c-3 after first pass with device	Procedure
Successful Revascularization at end of procedure	mTICI (modified TICI) 2b-3 at the end of procedure	Procedure
Successful Revascularization at end of procedure	mTICI (modified TICI) 2c-3 at the end of procedure	Procedure

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.
• Investigators: Principal Investigator: Boris Pabon, MD, Angiosur

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 19, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 101929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No